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STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (AML)

NCT05519527•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This is an open-label, phase 1b/2 trial. It is designed to identify the recommended phase 2 dose (RP2D) of STI-6129, and the safety and efficacy of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of R/R T-ALL and AML who have exhausted standard of care treatment.

Detailed Description

Primary Objective: * To assess in patients with R/R T-ALL or AML * Maximum tolerated dose of STI-6129 * Phase 2 recommended dose * Safety of STI-6129 Secondary Objectives: * Efficacy of STI-6129, overall response rate (CR+CRi+MLFS) * Evaluate rate of negative measurable residual disease (MRD) * Evaluate overall survival, duration of response, event-free survival * No. of patients transitioning to stem-cell transplantation Exploratory Objectives: \- Evaluate the association of biomarkers with safety and efficacy in patients with R/R T-ALL or AML treated with STI-6129 CD38 ADC STI-6129 - R/R T-ALL, AML

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age greater than or equal to 18 years.
•2. Confirmed diagnosis of R/R T-ALL or R/R AML by bone marrow evaluation. Note that patients must have failed treatment with available therapies known to be active for treatment of their T-ALL/AML
•3. ECOG performance status of 0, 1, or 2
•4. Pulse oximetry greater than or equal to 92% on room air
•5. Be willing and able to comply with the study schedule and all other protocol requirements
•6. Females of childbearing potential (FCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative pregnancy test during the Screening Period prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study

Exclusion Criteria

•1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 months or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require further active treatment or is well under control
•2. Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant.
•3. Must be off calcineurin inhibitors for at least 4 weeks prior to study treatment.
•4. New York Heart Association (NYHA) class greater than or equal to 3
•5. Left ventricular ejection fraction (LVEF) \< 40%.
•6. The following baseline chemistry laboratory results at Screening:
•1. Serum creatinine \> 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance \< 60 mL/min (using the Cockcroft-Gault equation).
•2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x the upper limit of normal (ULN) or serum total bilirubin \> 1.5x ULN (except for patients in or leukemia involvement)
•7. Pregnancy or currently breastfeeding
•8. Patients with greater than Grade 3 neuropathy or Grade 2 neuropathy with associated pain
+4 more criteria

Key Dates

Start Date

August 16, 2022

Primary Completion Date

February 15, 2023

Completion Date

February 15, 2023

Last Updated

August 31, 2023

Conditions

Refractory T Acute Lymphoblastic LeukemiaAcute Myeloid Leukemia (AML)

Interventions

Part 1 (STI-6129)

DRUG

Part 2 (STI-6129)

DRUG

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

NCT06660368

Relapsed or Refractory Acute Myeloid Leukemia (AML)

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CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT05143996

Relapsed/Refractory Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

Inclusion Criteria

Exclusion Criteria

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